Under the contract Covalent will support Emergent BioSolutions’ development program by providing project management, study site management, field operations, data management, biostatistical services, and medical writing services.
The anthrax immune globulin (AIG) product being developed by Emergent is anticipated to be an intravenous formulation with high levels of antibodies to protect against anthrax infection.
Immune globulins are being used increasingly in the treatment of diseases mediated by circulating toxins such as tetanus and botulism, and specific infections such as hepatitis B, cytomegalovirus and Staphylococcus aureus.
Emergent BioSolutions has been collecting plasma containing high levels of anthrax antibodies over the past year from donors who have been vaccinated with the company’s anthrax vaccine, BioThrax.
“This agreement represents a significant step in our effort to bring an effective anthrax treatment to market,” stated Dr Steven Chatfield, chief scientific officer of Emergent BioSolutions. “The resources being provided by Covalent are intended to facilitate a near term expansion of our program and provide us with a unique opportunity to leverage our own supply chain and build a large scale production base.”